The company is working with regulators in the U.S., Europe and the UK to find ways to gain approval for this drug for the treatment of COVID-19. Read More

The recall was issued following a report of a foreign body found in one vial at a vaccination center in Spain. Read More

As of December 2021, only 17 million doses of the adenovirus-based J&J vaccine were administered in the U.S. Read More

In its complaint, Acuitas argues that Arbutus and Genevant had nothing to do with the vaccine’s success and only sued after the Pfizer/BioNTech COVID-19 vaccine achieved “worldwide commercial success.” Read More

The FDA has accused two overseas companies of selling unapproved and misbranded drugs for COVID-19 to U.S. customers over the internet. Read More

Sanofi and GlaxoSmithKline (GSK) will very soon be taking their COVID-19 vaccine candidate to U.S. and European regulators as both a primary series and booster, touting its 58 percent efficacy against symptomatic disease as proof that the shot works in a world with multiple COVID-19 variants. Read More

Pfizer and BioNTech announced Friday that they will hold off pursuing an expanded FDA Emergency Use Authorization (EUA) permitting use of their COVID-19 vaccine in children under age five, in order to gather more data on whether a third booster dose is needed. Read More

In a 269-page submission to U.S. Trade Representative, Katherine Tai, the Pharmaceutical Research and Manufacturers of America (PhRMA) spelled out the group’s objections to efforts by the World Health Organization (WHO) and other organizations to expand COVID-19 vaccines and treatments at the expense of intellectual property rights. Read More

Protection against Omicron-related death in people 50 and older reached as high as 95 percent after a booster dose of a messenger RNA (mRNA) vaccine, the UK Health Security Agency (UKHSA) announced Thursday. Read More

A Moderna or Pfizer/BioNTech COVID-19 booster dose was found to give highly effective protection against the Delta and Omicron variants, the Centers of Disease Control and Prevention (CDC) said Friday. Read More

GlaxoSmithKline (GSK) and Vir Biotechnology have developed an intramuscular version of their investigational monoclonal antibody infusion, sotrovimab, for the early treatment of COVID-19 and are asking the FDA to expand the drug’s Emergency Use Authorization (EUA) to include it. Read More

As the Omicron variant rages, Peter Marks, the FDA’s top vaccine regulator, said that getting a booster dose earlier than six months after initial doses may be the best way to guard against the ubiquitous variant. Read More